For the purpose of this application, the following terms have the following meanings: “Probiotic” means live bacteria (also called microflora or microorganisms) that confer a beneficial effect when an effective amount is introduced into the intestinal tract of a mammal. “Prebiotic” means any substance that can be consumed by a relevant probiotic, or that otherwise assists in keeping the relevant probiotic alive or stimulates its growth, and includes mucopolysaccharides, oligosaccharides, polysaccharides, amino acids, vitamins, nutrient precursors and proteins. “Compliment” or “complimentary” with respect to a prebiotic means that the prebiotic is consumed by, or otherwise assists in keeping alive or stimulates the growth of, a relevant probiotic. “Beneficial substance” means a prebiotic, probiotic or composition comprising probiotic and prebiotic. “Effective amount” means any non-zero amount of a beneficial substance that is introduced into the intestinal tract of a subject, wherein the beneficial substance is not inherently present in food stuffs being introduced into the subject's gastrointestinal tract. “Intestinal tract” or “gastrointestinal tract” means the tract from the mouth to the anus and includes the stomach and intestines (including the ileum, duodenum, jejunum, caecum, crasum (large intestine), rectum, and tenue (small intestine, which includes the tenue mesenteriale). “Delivery tube” means any passageway or conduit inserted into or otherwise placed in the body for introducing a beneficial substance directly into a part of the intestinal tract, and includes enteral feeding tubes. “Downstream” or “beneath” means any part of the intestinal tract downstream of the organ referenced. “Upstream” means any part of the body upstream of the organ referenced. “Subject” means a mammal to which a beneficial substance is administered.
Certain bacteria (included in the foregoing definition of probiotic) have been shown to be beneficial to human gastrointestinal health. The human gastrointestinal tract contains an estimated 100×109 viable bacteria, representing as many as 100 or more different species. About Probiotics, www.probiohealth.com. While few microorganisms are found in the stomach because of its high acidity, their numbers increase downstream of the stomach. Natasha Trener, Probiotics: The Foundation of Your Health, Now and Forever (Excerpts), www.natren.com. The greatest numbers and variety are found in the large intestine. Id.
Probiotics assist in keeping harmful pathogenic species in check. At least some probiotics attach to the intestinal wall and produce a mildly acidic environment (in part due to the excretion lactic acid) that curbs the growth of certain harmful, disease-causing bacterial species. About Probiotics, supra. Probiotics are also believed to assist in important nutrient assimilation, producing many important enzymes and potentially increasing the bioavailability of, and synthesizing, some vitamins (particularly the Bs and K), fatty acids, lactase, and calcium. Why You Need to Take The Friendly Probiotic Bacteria in Friendly Colonizer, www.elexacom.
Among other benefits conferred by probiotics are believed to be: strengthening of the immune system, neutralization of toxins, normalization of bowel movements, control of cholesterol, countering of allergies and skin problems, and the prevention of yeast and fungal infections. About Probiotics, supra; Probiotics: The Foundation of Your Health, Now and Forever, supra; Why You Need to Take the Friendly Probiotic Bacteria for Friendly Colonizer, supra.
The major bacteria in the intestines can be roughly divided into three groups: (a) lactic acid bacteria, including Lactobacilli, Bifidobacteria, and streptococci; (b) anaerobic bacteria; and (c) aerobic bacteria. At least Lactobacilli, Streptococci, and Bifidobacteria confer beneficial effects to mammals, particularly humans, and are included in the definition of probiotic herein.
Lactobacilli (i.e., bacteria of the genus Lactobacillus, abbreviated as “L.”) have been used for several hundred years as food presentations and for promoting human health. About Probiotics. supra Lactobacilli found in the human intestinal tract include L. acidophilus, L. casei, L. fermentum, L. saliva roes, L. brevis, L. leichmannii, L. plantarum, and L. cellobiosus. 
L. acidophilus has been shown to be useful in treating conditions such as antibiotic-induced imbalances in the gastrointestinal microflora, hypercholesterolemia, vaginal infections, E. coli infection, depressed immunity, cancerous tumors, chronic granulomatous disease, and lactose indigestion. A. G. Shauss, Method of Action, Clinical Application, and Toxicity Data, 3 J. Advancement Med. 163 (1990). It has also been shown that the activities of fecal bacterial enzymes thought to play a role in conversion of procarcinogens to carcinogens, such as betaglucuronidase, glucuronidase, nitroreductase, and azoreductase, were reduced 2- to 4-fold in persons taking L. acidophilus supplements. B. R. Goldin & L. S. Gorbach, “The Effect of Milk and Lactobacillus Feeding on Human Intestinal Bacterial Enzyme Activity,” 39 Amer. J. Chin. Nutr. 756 (1984). These results suggest that dietary supplementation with L. acidophilus may reduce the risk of developing colon cancer.
Lactobacilli also produce organic acids that reduce intestinal pH thereby inhibiting the growth of acid-sensitive undesirable bacteria. Why You Need to Take the Friendly Probiotic Bacteria for Friendly Colonizer, supra. Lactobacilli produce lactic acid, hydrogen peroxide, and possibly acetic and benzoic acids. In vitro studies have shown L. acidophilus to inhibit the growth of pathogenic bacteria such as Campylobacter pylori, Staphylococcus aureus, Pseudomonas aeruginosa, and Sarcina lutea. K. M. Shahani et al., “Natural Antibiotic Activity of Lactobacillus Acidophilus and Bulgaricus,” 11Cultured Dairy Products J. 14(1976).
Bifidobacteria are also known to exert a beneficial influence on human health. These bacteria exert antimicrobial activity in the human intestine by producing short chain fatty acids (SCFAs) such as acetic, propionic, and butyric acids, as well as lactic and formic acids, as a result of carbohydrate metabolism. The most plentiful SCFA produced by Bifidobacteria is acetic acid, which is an antimicrobial to gastrointestinal pathogens such as yeasts, molds, and certain other bacteria. Further, both Lactobacilli and Bifidobacteria may produce other antimicrobial substances, such as bacteriocins, that also inhibit the growth and proliferation of certain harmful bacteria.
Additionally, SCFAs are believed to support normal gastrointestinal function by increasing colonic blood flow, stimulating pancreatic enzyme secretion, promoting sodium and water absorption and intestinal mucosal growth. Bifidobacteria are also believed to deconjugate bile salts to free bile acids, which are more inhibitory to susceptible bacteria than are the conjugated forms.
Therapeutic applications of Bifidobacteria are used to treat diarrhea, constipation, and hepatic encephalopathy with hyperammonemia. Additional benefits are believed to include the production of B vitamins and breakdown of carcinogenic N-nitrosamines.
Bifidobacteria constitute the predominant microorganisms in the fecal microflora of week-old breast-fed infants, making up 85-99% of the bacterial population. Upon weaning or upon an event such as an infection, vaccination, or a sudden change in diet, the balance of microorganisms in the gastrointestinal tract of these babies can be upset. The Bifidobacterial population in adults is generally stable. However, changes in diet, administration of antibiotics, exposure to gamma radiation or X-rays, disease, pollutants, stress, or other disturbances can result in an overgrowth of potentially pathogenic bacteria and/or a decrease in beneficial bacteria (e.p., Lactobacilli and/or Bifidobacteria). About Probiotics, supra. Bifidobacteria numbers can be significantly reduced in elderly people for other reasons, for example, due to a reduction of secreted gastric juices.
Without sufficient numbers of probiotics, intestinal ecology may be thrown off balance, which can potentially result in health problems. Probiotic supplements may be used to increase the number of probiotics in the intestinal tract. About Probiotics, supra. As mentioned in “Probiotics, Prebiotics & Synbiotics: Harnessing Enormous Potential,” Nutraceuticals World (September 2001), a trend regarding probiotics is finding novel delivery systems, particularly because acidity in the stomach is detrimental to many probiotics and may destroy as much as 90-95% of such probiotics during their passage through the stomach. To date, improving the protection of probiotics from stomach acid has included using enteric coated capsules and microencapsulation. Such types of microencapsulation include technology known as Probiocap™ by Institut Rosell.
Known prebiotics include dietary fibers, such as polysaccharides and oligosaccharides, that have the ability to increase the number of probiotic, which leads to the benefit(s) conferred by the probiotic. For example, an increase of beneficial Bifidobacteria is likely to change the intestinal pH to support an increase of Bifidobacteria, and which decreases pathogenic organisms. A prebiotic may also provide one or more of the following benefits: (1) indirectly produce short chain fatty acids (SCFAs) that in turn have a trophic (nourishing) effect on the intestinal epithelium, supporting its integrity as a defense barrier against invading organisms; (2) indirectly produce immune stimulants, by the promotion of Bifidobacteria that excrete an end product inhibitory to pathogenic bacteria; (3) promote a host-mediated attack against tumor sites and promote certain strains of Lactobacilli that have immune-modulating activity, enhancing phagocyte activity in the blood; and (4) indirectly provide any of the benefits of an increased number of probiotic whose number increased due at least in part to the presence of the prebiotic. A prebiotic may also affect the production of certain bacteria enzymes, such as decreasing glucosidase that is associated with the absorption of intestinal cholesterol, associated with the formation of secondary bile acid that is considered a co-carcinogen.
However, while known prebiotics break down to provide carbohydrates for probiotics, some probiotics also require amino acids for nourishment.
It would therefore be desirable to have a prebiotic that was resistant to stomach acids and that provided carbohydrates and amino acids to support probiotic growth. It would also be desirable to introduce a probiotic into the intestinal tract in a manner that alleviates the destruction caused by stomach acid and enables the probiotic to quickly enter the intestines, where it can be of most benefit.